Evaluation of an offline, artificial intelligence system for referable glaucoma screening using a smartphone-based fundus camera: a prospective study.

BACKGROUND/OBJECTIVES: An affordable and scalable screening model is critical for undetected glaucoma. The study evaluated the performance of an offline, smartphone-based AI system for the detection of referable glaucoma against two benchmarks: specialist diagnosis following full glaucoma workup and consensus image grading. SUBJECTS/METHODS: This prospective study (tertiary glaucoma centre, India) included 243 subjects with varying severity of glaucoma and control group without glaucoma. Disc-centred images were captured using a validated smartphone-based fundus camera analysed by the AI system and graded by specialists. Diagnostic ability of the AI in detecting referable Glaucoma (Confirmed glaucoma) and no referable Glaucoma (Suspects and No glaucoma) when compared to a final diagnosis (comprehensive glaucoma workup) and majority grading (image grading) by Glaucoma specialists (pre-defined criteria) were evaluated. RESULTS: The AI system demonstrated a sensitivity and specificity of 93.7% (95% CI: 87.6-96.9%) and 85.6% (95% CI:78.6-90.6%), respectively, in the detection of referable glaucoma when compared against final diagnosis following full glaucoma workup. True negative rate in definite non-glaucoma cases was 94.7% (95% CI: 87.2-97.9%). Amongst the false negatives were 4 early and 3 moderate glaucoma. When the same set of images provided to the AI was also provided to the specialists for image grading, specialists detected 60% (67/111) of true glaucoma cases versus a detection rate of 94% (104/111) by the AI. CONCLUSION: The AI tool showed robust performance when compared against a stringent benchmark. It had modest over-referral of normal subjects despite being challenged with fundus images alone. The next step involves a population-level assessment.

XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study.

PRCIS: XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice. PURPOSE: To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open angle glaucoma. METHODS: This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. "Complete" surgical success at 60 months was defined as unmedicated IOP ≤15 mm Hg and a relative IOP reduction ≥20% from medicated baseline, while "qualified" success allowed fewer ocular hypotensive medications than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP-lowering medication changes and rates of reoperations. RESULTS: Mean age was 78.1±9.2 years, and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7 mm Hg [19.6±7.1 (XEN) vs. 19.8±7.0 mm Hg (Phaco+XEN)] at baseline to 12.6±3.1 mm Hg [12.5± 3.1 (XEN) vs. 12.6±3.1 (Phaco+XEN)] at 5 years (-37.0%; P < 0.001). Medications decreased from 2.0±1.3 [2.0±1.3 (XEN) vs. 2.0±1.3 (Phaco+XEN)] to 0.8±1.1 [0.8±1.1 (XEN) vs. 0.8±1.1 (Phaco + XEN)] (-60%; P <0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (odds ratio: 3.06, P <0.01), while needling was associated with higher rates of failure (odds ratio: 3.6, P <0.01). CONCLUSIONS: At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.

EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Outcomes of Deep Sclerectomy following Failed XEN Gel Stent Implantation in Open-Angle Glaucoma: A Prospective Study.

Background: The purpose of this study is to evaluate the outcome of deep sclerectomy (DS) as a secondary procedure following failed ab-interno XEN gel stent implantation in patients with open-angle glaucoma. Methods: Prospective, single-center, non-randomized, interventional study. Consecutive eyes that underwent mitomycin C (MMC) augmented XEN gel stent surgery, with uncontrolled intraocular pressure (IOP) or signs of disease progression, were included to undergo MMC-augmented DS. Primary efficacy outcome was surgical success, defined as complete when the unmedicated IOP was 12 mmHg or less, or 15 mmHg or less and 20% lower than at the timing of XEN failure and defined as qualified when the IOP fulfilled the same conditions with fewer medications than before deep sclerectomy. Secondary measures were mean reduction in IOP and in the number of medications, and the rates of complications. Results: Seventeen eyes were enrolled with a mean age of 72.1 ± 8.2 years (66.7% women). The mean follow-up was 20.1 ± 4.9 months, with more than 12-month data available from 15 eyes. Following DS, IOP decreased significantly from 22.6 ± 5.3 mmHg to 12.3 ± 5.5 (45.6%; p < 0.001). Antiglaucoma medications dropped from 1.1 ± 0.9 to 0.3 ± 0.7. Complete success was obtained in 40% of eyes using the threshold of 12 mmHg or less and a 20% decrease of IOP, and in 60% using the 15 mmHg or less threshold. Adverse events were observed in 20% of eyes (bleb leakage (13.3%); hypotony (6.7%)). No cases of choroidal detachment or hypotony maculopathy were reported. Conclusions: Failed XEN gel stent implantation does not seem to negatively affect the safety and efficacy of subsequent deep sclerectomy surgery.

Long-term outcomes and risk factors for failure of glaucoma filtering surgery in eyes with vernal keratoconjunctivitis and steroid-induced glaucoma.

PURPOSE: To report outcomes and assess the risk factors for failure of trabeculectomy (trab), trabeculectomy with mitomycin-C (trabMMC), and combined trabeculectomy with cataract extraction (CT) in vernal keratoconjunctivitis (VKC) eyes with steroid-induced glaucoma (SIG). METHODS: Trab was performed in 45 eyes of 30 subjects, trabMMC in 36 eyes of 25 subjects, and CT in 34 eyes of 27 subjects. Success was complete when intraocular pressure (IOP) was between 6 and 21 mm Hg without anti-glaucoma medications (AGM) and qualified with AGM. RESULTS: Median age (14 vs. 16.3 and 17.4 years) was significantly less in the trab cohort (P = 0.007). Majority (88%-93%) were male (P = 0.78). Preoperatively, median duration of steroid usage was >2 years (P = 0.52), mean IOP (32, 29.4, and 28.4; P = 0.26) and median cup:disc ratio (CDR) (0.9; P = 0.27) were similar in the three groups. Complete success (76%, 71%, and 66% at 5 years; P = 0.91), and qualified success (88%, 97%, and 94% at 5 years; P = 1.0) with trab, trabMMC, and CT, respectively, were similar. Preoperative factors significantly associated with qualified failure (multiple logistic regression) were older children, longer duration of VKC, longer duration and mixed type of steroid use (all P < 0.001) and larger CDR (P < 0.02). At the last follow-up, 38% in trab, 33% in trabMMC, and 50% eyes in CT were blind (visual acuity ≤20/400 and/or visual field ≤10°) due to glaucoma (P = 0.33). CONCLUSION: The surgical success for all three types of surgery was similar at 5-years. Chronic VKC and long-term steroid use were associated with surgical failure. The majority had advanced disease and a significant proportion were blind due to glaucoma.

Upregulated NOTCH Signaling in the Lens of Patients With Pseudoexfoliation Syndrome Compared With Pseudoexfoliation Glaucoma Suggests Protective Role.

PRCIS: NOTCH signaling is significantly upregulated in the lens capsules of eyes with pseudoexfoliation syndrome (PXF) but not in those with pseudoexfoliation glaucoma (PXG) when compared with healthy controls. PURPOSE: NOTCH signaling has neuroprotective functions and altered NOTCH signaling is associated with neurodegenerative diseases with protein aggregation such as Alzheimer disease. As PXG is also a protein aggregate disease associated with neural degeneration, NOTCH molecular expression was explored in the lens capsules of patients with PXF, PXG, primary open-angle glaucoma (POAG), and healthy controls. METHODS: Anterior lens capsules were collected from 106 patients (27 PXF, 24 PXG, 22 POAG, and 33 controls) undergoing cataract surgery. Gene expression profiling for NOTCH pathway molecules (ligands, receptors, and downstream target genes) was performed on the tissue using a quantitative reverse transcription-polymerase chain reaction. The results were confirmed by protein analysis using dot-blot or immunostaining techniques. RESULTS: There was no difference in the demographic characteristics between the groups. There was an increase in NOTCH4 receptor expression (>14-fold) in the PXF group as compared with the controls. Similarly, the Delta-like 3 and Delta-like 4 ligands were significantly elevated in the PXF group compared with controls (P<0.05). Downstream targets HES3, HES5, and HEY1 expression were significantly elevated (P<0.005) in PXF lens capsules, confirming a higher activity of NOTCH signaling in this cohort. Immunostaining also corroborated the gene expression profile. CONCLUSION: The finding that NOTCH signaling is significantly upregulated in the lens capsule of eyes with PXF and not in PXG or POAG patients suggests a possible protective role in the development of glaucoma.

Outcomes of trabeculectomy in eyes with refractory acute primary angle-closure in Indian eyes.

PURPOSE: To report the outcomes of trabeculectomy in eyes with refractory acute primary angle-closure attack. METHODS: Patients with acute primary angle-closure attack and who underwent trabeculectomy for medically uncontrolled intraocular pressure within 2 months of presentation were retrospectively analyzed. Primary outcome was intraocular pressure (IOP). Secondary outcome measures were visual acuity, number of antiglaucoma medication (AGM), complications, and risk factors for failure of trabeculectomy. RESULTS: Thirty-five eyes of 31 patients with median (interquartile range) follow-up of 3 (0.5, 9) years were included in the study. Median age at presentation was 55 (47, 60) years. Median duration of symptoms at presentation was 10 (4, 16) days and median time from presentation to surgery was 13 (6, 25) days. Median IOP reduced from 42 (36, 46) to 13 (12, 16) mmHg (P < 0.001) and median number of AGM reduced from 3 (1, 3) to 0 (0, 0) after trabeculectomy at the end of 1 year. The probability of complete and qualified success was 88% (95% confidence interval [CI]: 72%-95%) and was 97% (95% CI: 81%-99%) at 1 year, respectively. Failure was noted in six eyes. Subsequent cataract surgery was needed in 13 eyes (37%) with a median duration from trabeculectomy being 6.75 (1, 11) years. None of the preoperative, intraoperative, or postoperative factors tested were associated with failure (P > 0.10 for all associations on Cox proportional hazard regression analysis). CONCLUSION: In medically unresponsive cases of acute primary angle-closure attack, primary trabeculectomy seems safe and effective in Indian eyes.

Phacoemulsification versus Phacotrabeculectomy in Medically Controlled Primary Angle Closure Glaucoma with Cataract in an Indian Cohort: A randomized controlled trial.

PURPOSE: To compare the outcomes of phacoemulsification with phacotrabeculectomy in primary angle closure glaucoma (PACG) eyes with medically controlled intraocular pressure (IOP). METHODS: Prospective, randomized control trial including 33 eyes of 33 patients who underwent phacoemulsification (Phaco) and 37 eyes (37 patients) who underwent phacotrabeculectomy (PT). The primary outcome measure was survival defined as IOP control (IOP ≥ 6 and ≤ 21 mmHg without antiglaucoma medications (AGM) at different time points. Secondary outcome measures were the rate of visual recovery and complications. RESULTS: The mean age in years (PT: 58.5 ± 9.8, Phaco:61.6 ± 8.9; p = 0.16), preoperative mean deviation in decibel (PT: -18.7 ± 9.3; Phaco: -16.6 ± 7.9; p = 0.32) and the mean follow up in years (PT: 2.5 ± 1.8; Phaco: 2.8 ± 2.0; p = 0.63) were similar in the two groups. The mean preoperative AGMs were more in the PT group (PT: 2.13 ± 0.97, Phaco: 1.60 ± 0.78; p = 0.01). In both the groups the survival was similar at all-time points (PT: 78% at 1-year and 52% at 5-years, Phaco: 80% at 1 year and 59% at 5 years (P = 0.82). The postoperative visual acuity in LogMAR was significantly better in the Phaco group at 1 month (PT: 0.22 ± 0.38, Phaco:0.06 ± 0.07; p = 0.02). Postoperative AGM (p = 0.68) and rate of visual field progression PT: -0.46 ± 0.41 dB/year; Phaco: -0.38 ± 0.73 dB/year; p = 0.67) were similar in both groups. One eye in PT group developed malignant glaucoma which resolved with laser hyaloidotomy and cycloplegic therapy. CONCLUSIONS: More rapid visual recovery with similar IOP control and similar visual field stability favor phacoemulsification to phacotrabeculectomy in medically controlled PACG eyes with cataract.

Combined and stand-alone XEN 45 gel stent implantation: 3-year outcomes and success predictors.

PURPOSE: To evaluate the 3-year treatment outcomes of XEN 45 gel stent in open-angle glaucoma patients. METHODS: In this prospective, single-centre interventional study, consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment underwent XEN implantation either alone or combined with phacoemulsification (Phaco + XEN). MAIN OUTCOME MEASURES: Surgical success was defined as 'complete' when 36-month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline, while the definition of qualified success allowed no more medications than at baseline. Other definitions of success with different IOP thresholds were also analysed. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications and rates of reoperations. RESULTS: Out of 149 eyes initially included, 92 eyes (61.7%) of 68 patients had complete 3-year data (XEN: n = 26; Phaco + XEN: n = 66) after 38.2% were lost to follow-up. Mean age was 76.3 ± 9.1 years, and 66.2% were female. Mean medicated IOP decreased from 20.8 ± 7.4 mmHg (21.0 ± 7.4 [XEN] vs. 20.0 ± 6.9 mmHg [Phaco + XEN]) at baseline to 13.1 ± 3.4 mmHg (12.9 ± 2.9 [XEN] vs. 12.9 ± 3.4 [Phaco + XEN]) at 3 years (-37.0%; p < 0.001). Medications decreased from 1.9 ± 1.3 (2.4 ± 1.5 [XEN] vs. 1.9 ± 1.2 [Phaco + XEN]) to 0.4 ± 0.9 (0.3 ± 0.8 [XEN] vs. 0.5 ± 0.9 [Phaco + XEN]) (-78.9%; p < 0.001). Complete success and qualified success were achieved in 29.0% and 31.0% of eyes, respectively. Needling revision was performed in 51 eyes (55.4%), and 26.1% underwent reoperations. Risk factors for surgical failure included male gender (odds ratio [OR]:3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01) and undergoing needling revision (OR: 4.6; p < 0.01). While the type of procedure had no effect on the outcomes of PEXG, POAG eyes undergoing combined surgery had significantly higher rates of failure (OR: 7.29; p = 0.023). Most patients stable at 12-month remained so through to 3 years. CONCLUSIONS: At 3 years, XEN gel stent implantation achieved clinically significant IOP and medication reduction despite relatively high rates of needling and reoperations. Identifying patients at risk preoperatively may help optimize surgical outcomes.

Outcomes of pattern scanning laser trabeculoplasty and selective laser trabeculoplasty: Results from the lausanne laser trabeculoplasty registry.

PURPOSE: To compare the long-term safety and efficacy of pattern scanning laser trabeculoplasty (PSLT) and selective laser trabeculoplasty (SLT). METHODS: This was a retrospective database analysis (Lausanne Laser Trabeculoplasty Registry) of patients having had laser trabeculoplasty (LT) prior to 2017 with a minimum follow-up of 1 year. Inclusion criteria were age ≥40 years and diagnosis of ocular hypertension (OHT) and open-angle glaucoma (OAG). Selective laser trabeculoplasty (SLT) eyes were matched to PSLT eyes according to baseline intraocular pressure (IOP), baseline number of ocular hypotensive medications (OHM) and glaucoma diagnosis. Success was defined as an IOP ≤ 20% from baseline or an IOP equal or lower than baseline accompanied by a reduction in OHM. Multivariate regression models were used to study associations between success and baseline clinical parameters. RESULTS: From 280 eyes in the database, 81 eyes had PSLT and were matched with 81 SLT eyes (162 patients). Mean age was 69.4 ± 12.1 years, and 56.2% were female. Mean IOP was 18.6 ± 5.3 and 18.2 ± 4.1 mmHg at baseline and 15.9 ± 3.0 and 16.0 ± 3.4 mmHg at 12 months and 15.2 ± 2.7 and 16.2 ± 3.4 mmHg at 24 months, for PSLT and SLT, respectively. 60.5% of PSLT and 65.4% of SLT eyes achieved treatment success (p = 0.20). Number of OHM was 1.0 ± 1.0 and 1.4 ± 1.2, respectively (p = 0.052). Baseline IOP (OR = 1.23, p < 0.01) and number of OHM (OR = 1.67, p < 0.01) were associated with success in both PSLT and SLT, while LT modality was not [OR = 0.81 (0.43-1.53), p = 0.52], and a diagnosis of primary OAG was negatively associated (OR = 0.42, p = 0.04). CONCLUSION: Our study did not find any significant differences between PSLT and SLT in terms of safety and efficacy in patients with OHT and glaucoma. Baseline IOP was associated with higher success rates in both procedures. Additional studies are needed to evaluate the outcomes of PSLT in non-Caucasian populations and the ability of repeat PSLT to achieve additional IOP reduction.

Effect of Intravenous Dexmedetomidine on Intraocular Pressure in Patients Undergoing Glaucoma Surgery Under Local Anesthesia: A Pilot Study.

PRECIS: Preoperative intravenous (IV) dexmedetomidine produced a 33% reduction in intraocular pressure (IOP) within 15 minutes of administration in patients with glaucoma. PURPOSE: To evaluate the effect of preoperative IV dexmedetomidine on IOP in adult patients undergoing glaucoma surgery under local anesthesia. METHODS: In a prospective interventional case series, 12 patients with uncontrolled IOP (IOP>24 mm Hg in both the eyes) with the systemic status of American Society of Anesthesiologists (ASA) classification I-II, received IV dexmedetomidine 0.6 µg/kg 30 minutes preoperatively. The IOP of the nonsurgical eye (measured with Perkins tonometer), the heart rate (HR), and blood pressure (BP) were recorded 5 minutes prior, 15 minutes and 2 hours after IV dexmedetomidine administration, and were compared using analysis of variance and Tukey honestly significant difference tests. RESULTS: There were 4 women and 8 men with a mean age (±SD) of 60.6±10.4 years. The mean number of antiglaucoma medications was 4.3±1.3. The mean pre-dexmedetomidine IOP was 31.5±5.6 mm Hg. At 15 minutes post-dexmedetomidine administration, the mean and percentage drop in IOP were 10.2±3.2 mm Hg (P=0.001) and 33%±11%, respectively. The mean and percentage drop in systolic BP were 18±20 mm Hg (P=0.01) and 12%±14%, and drop in diastolic BP were 6.5±10 mm Hg (P=0.05) and 7%±11%, respectively. The mean and percentage drop in HR were 2±0.6 bpm (P=0.48) and 2%±13%, respectively. None of the subjects experienced any medication-related adverse effects. At 2 hours, the mean and percentage drop in IOP were 5.3±3 mm Hg and 17%±11%, respectively. CONCLUSION: In the small sample of (ASA I-II) patients studied, preoperative dexmedetomidine produced a significant drop in IOP (33%) within 15 minutes of IV administration in patients with glaucoma that was reversing at 2 hours, with a good safety profile.

XEN-augmented Baerveldt drainage device implantation in refractory glaucoma: 1-year outcomes.

PURPOSE: To evaluate outcomes of XEN-augmented Baerveldt drainage device implantation in refractory glaucoma and factors predicting surgical success. METHOD: All eyes undergoing XEN-augmented Baerveldt for refractory open-angle glaucoma at a tertiary glaucoma centre between January 2016 and November 2017 were retrospectively enrolled. Intraocular pressure (IOP), number of anti-glaucomatous medications and postoperative adverse events (AEs) were analysed for 1 year postoperatively. Surgical success was defined as achieving (1) an IOP ≤ 15 mmHg or (2) ≤ 18 mmHg, with or without (qualified) or without medications (complete). Any subsequent glaucoma surgery was considered failure. RESULTS: Out of 60 eyes enrolled, 12-month data were available for 41 eyes (71.4%). Mean age was 64.7 ± 23.1 years (50% female). Following surgery, IOP decreased significantly from a baseline of 29.9 ± 13.2 to 15.2 ± 6.6 mmHg (- 49.2%; P < 0.0001) at 12 months. Anti-glaucoma medications decreased from 3.0 ± 1.3 to 1.3 ± 0.9. Complete success was achieved by 14.6% of eyes using both the ≤ 15 mmHg and the ≤ 18 mmHg thresholds, and qualified success was achieved in 43.9% and 48.8%, respectively. Throughout the follow-up period, AEs were observed in 51.2% (hypotony = 24.4%; XEN blockage = 17.1%; displacement of XEN gel stent = 4.9%; hyphema = 4.9%). The 12-month success rate was significantly higher in patients who presented an IOP ≤ 10 mmHg at 1 week (58.6%, P = 0.001). Overall, 41.5% of patients required reoperation at 12 months (58.8% revision of the surgery; 41.2% transscleral cyclodestruction). CONCLUSION: XEN-augmented Baerveldt is a safe and moderately effective technique to reduce IOP and anti-glaucoma medications in refractory glaucoma. IOP at 1 week seems to be a predictor for surgical success. Nevertheless, a high proportion of patients requires reoperation.

Predictors of Success in Selective Laser Trabeculoplasty: Data From the Lausanne Laser Trabeculoplasty Registry.

PURPOSE: The purpose of this study was to determine the factors associated with the outcomes of selective laser trabeculoplasty (SLT). PATIENTS AND METHODS: This was a database analysis (Lausanne Laser Trabeculoplasty Registry) of patients who had SLT between 2015 and 2017. Exclusion criteria were age below 40 years and diagnosis other than ocular hypertension and open-angle glaucoma. Intraocular pressure (IOP) and number of medications were recorded before and at various follow-ups after laser treatment. Success was defined as "complete" if an IOP reduction of at least 20% was observed at a given time, and "qualified" if any reduction of IOP was observed with either at least a 20% difference from baseline or a reduction in IOP-lowering medications. Associations of complete and qualified success with patients' baseline characteristics, laser settings, and clinical examination findings were studied using multivariate regression and survival analysis. RESULTS: A total of 170 eyes (126 patients) were included. Mean age was 68.3±12.2 years and 57.9% of the study cohort were female individuals. Average baseline IOP was 18.7±4.8 mm Hg, and average IOP reduction was 3.3±4.3 (-17.6% from baseline) and 3.5±3.9 mm Hg (-18.7% from baseline) at years 1 and 2, respectively. Male sex [odds ratio (OR)=2.79, P=0.02], baseline IOP (OR=1.15, P<0.01), and medical treatment before SLT (OR=2.57, P=0.03) were positive predictors of success. Total energy was associated with the duration of success. SLT outcome was strongly correlated to the outcome of the fellow eye, which represented the strongest predictor (OR=17.33, P<0.01). CONCLUSIONS: SLT achieved good IOP-lowering in a majority of patients with mild-to-moderate glaucoma, while it was inefficient in up to 35% of eyes. SLT success in the fellow eye was a strong predictive factor.

Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes.

BACKGROUND/AIMS: Both eyes of a same person are not completely independent entities. The purpose of this study was to assess the difference in outcome between the first-operated eye and the fellow-operated eye following bilateral XEN surgery, and to identify potential success predictors for the fellow eye. METHODS: This single-site, prospective, nonrandomized interventional study investigated bilateral nonsimultaneous XEN gel stent implantation over 24 months. Its main outcome measure was surgical success, defined as unmedicated intraocular pressure (IOP) ≤15 mm Hg associated with a relative reduction ≥20%. RESULTS: Of 149 enrolled eyes, 74 eyes of 37 patients who underwent bilateral (standalone or combined) XEN implantation, within a mean of 50.5±74.3 days of each other, were analyzed. Postoperatively, mean medicated IOP decreased from 19.0±6.6 (first-operated) and 18.2±5.2 mm Hg (fellow) at baseline (P=0.209) to 13.7±4.0 (-27.9%; P<0.001; first-operated) and 14.1±3.6 mm Hg (-22.5%; P<0.001; fellow) after 2 years (P=0.673). Rates of complete success were comparable between first-operated and fellow eyes (P=0.65). At 2 years, among patients whose first-operated eyes were considered a failure, 92.0% of fellow eyes failed (P=0.001). The odd ratio of a fellow eye experiencing complete success were 16.1 (95% confidence interval: 2.5-101.9, P=0.003) if the first operated eye experienced complete success. CONCLUSIONS: The present study demonstrated a strong association between first-operated eyes and fellow eyes following XEN gel stent implantation, in terms of surgical outcomes and IOP reduction. In effect, surgical success in the first-operated eye increases the odds of success in the fellow eye by 16-folds.

Impact of Phacoemulsification Combined with XEN Gel Stent Implantation on Corneal Endothelial Cell Density: 2-Year Results.

INTRODUCTION: Corneal integrity has long been a preoccupation of glaucoma surgeons considering glaucoma drainage device surgery or antimetabolite-enhanced trabeculectomy. Despite having demonstrated a good safety profile and significant intraocular pressure-lowering capacities, the impact of XEN gel stents on endothelial density was never specifically investigated. The purpose of this study is to assess the effect of XEN gel stents on central endothelial cell density (ECD) over 24 months. To achieve this, we compared the effect on ECD of combined XEN surgery with that of a standard phacoemulsification procedure. METHODS: This was an investigator-initiated, retrospective study, conducted at a single tertiary glaucoma center. Patients with primary or secondary open-angle glaucoma who underwent XEN implantation combined with phacoemulsification between January 2015 and June 2016 were retrospectively enrolled. Patients who had undergone standalone phacoemulsification over the same period of time were enrolled to form the control group of this comparative study. The primary outcome measure was the ECD. Patients who had undergone standalone XEN implantation and patients for whom both a baseline and 24-month ECD could not be obtained were excluded from the analysis. Percentages of ECD reductions were calculated for each studied eye, and the mean of ECD reductions was calculated for each group as well as for subgroups. RESULTS: Thirty-two eyes of 23 patients (mean age=76.0±7.9 y, 60% female) underwent standalone phacoemulsification (n=15) or combined XEN surgery (n=17) and had an ECD both at baseline and 24-month postoperatively. Mean baseline ECDs were 2568±491 versus 2379±335 cells/mm, respectively (P=0.21). In the combined XEN surgery group, 58.8% of eyes (n=10) required at least 1 mitomycin C (MMC)-enhanced needling revision to maintain their target intraocular pressure. In the standalone phacoemulsification group, ECD decreased by a mean 14.5%, from 2567.7±491.2 to 2196.1±591.9 cell/mm (P=0.072). In the combined XEN surgery group, ECD decreased by a mean 14.3%, from 2378.8±334.7 to 2039.6±451.1 cell/mm (P=0.018). The difference in percentage reduction of ECD between the 2 groups was not statistically significant (P=0.226). Within the combined XEN surgery group, the ECD decreased by a mean of 15.4% in patients who did not undergo needling revisions and by 13.1% in patients who underwent the MMC-augmented procedure (P=0.485). In the 3 patients who underwent >1 needling revision, a 21.3% reduction in ECD was observed, but the difference was not statistically significant (P=0.653). Neither the time of the first needling (P=0.452), the patients' age (P=0.285), or sex (P=0.308) was statistically associated with ECD loss. DISCUSSION: The present study demonstrated that the XEN gel implant combined with phacoemulsification produces 24-month ECD loss of a similar magnitude to that observed following standalone phacoemulsification. MMC-augmented needling revisions do not appear to have an impact on ECD.

LVPEI Glaucoma Epidemiology and Molecular Genetic Study: teleophthalmology screening for angle-closure disease in an underserved region.

OBJECTIVES: To assess the ability of teleophthalmoscopic grading of peripheral anterior chamber depth (PACD) using the van Herick (vH) technique in detecting gonioscopically occludable angle; and to determine whether combining results from vH grading and ocular biometry can improve the accuracy to diagnose gonioscopically occludable angle METHODS: This cross-sectional study was an offshoot of a rural population-based study, Glaucoma Epidemiology and Molecular Genetic Study (GLEAMS). A masked urban ophthalmologist graded digital slit lamp photographs of PACD by vH technique. Sussman four-mirror lens was used to perform dark room indentation gonioscopy. Cutoff values of the tests were, vH technique: grade ≤ 2, central anterior chamber depth (ACD), as well as axial length: ≤ 25th percentile and lens thickness ≥ 75th percentile value of the study population. RESULTS: We studied 1965 eyes of 1029 adult participants. The vH grade was ≤2 in 188 (9.5%) eyes. The angle was occludable by gonioscopy in 101 (5.1%) eyes. The performance of the vH test to rule out gonioscopically occludable angle was good [negative predictive value (NPV): 97.3%], despite low sensitivity (52.5%), while its efficacy to rule in the condition was low [positive predictive value (PPV): 28.2%] despite high specificity (92.8%). However, test combination strategy increased the PPV nearly twofold (53.8%). The calculated PPV at 10% prevalence of gonioscopically occludable angle was even higher (70.5%). CONCLUSIONS: Van Herick technique can be incorporated into a teleophthalmology program by means of slit lamp photographs of PACD. Combined vH grading and ocular biometry improved the predictability of a gonioscopically occludable angle.

Effect of surgical intraocular pressure lowering on retinal structures - nerve fibre layer, foveal avascular zone, peripapillary and macular vessel density: 1 year results.

OBJECTIVES: To determine the effect of surgical intraocular pressure (IOP) lowering on peripapillary retinal nerve fibre layer thickness (RNFL), fovea avascular zone (FAZ), peripapillary and macular vessel density (VD) in glaucoma using with optical coherence tomography angiography (OCT-A). METHODS: This was a prospective observational study performed at the Glaucoma Research Centre, Montchoisi Clinic, Lausanne. In total 40 eyes with open-angle glaucoma were included. OCT-A scans were performed before glaucoma surgery, and at 1-month, 3-month, 6-month, and 12-month post-operatively. AngioVue AngioAnalytic (Optovue Inc, Fremont, CA) software was used to analyse the RNFL, FAZ, peripapillary and macular VD. Changes were analysed using analysis of variance (ANOVA) models. RESULTS: Mean IOP dropped from 19.4 (±7.0) mmHg pre-surgery and stabilized at 13.0 (±3.1) mmHg at 12 months (p < 0.001). The number of topical medications reduced from 2.2 (±1.2) preoperatively to 0.4 (±0.8) at 1 year (p < 0.001). Peripapillary RNFL thickness was transiently increased at 1-month postoperatively (p = 0.03). Peripapillary VD fluctuated throughout the follow-up. Foveal VD showed increased perfusion at 3 and 6 months post-operatively with minimal changes at 1 month (p < 0.01). Glaucoma surgery had a significant effect initially on FAZ area (p = 0.03), FAZ perimeter (p = 0.02) and Acircularity Index (AI) (p = 0.04). By 12-months FAZ measurements had reversed to baseline values. CONCLUSIONS: Peripapillary and macular microcirculations responded differently to surgically induced IOP reduction. Peripapillary microcirculation was IOP-independent within the studied range of surgically-controlled IOP. Macular microcirculation, however, exhibited a "delayed response" followed by near-normal reperfusion after glaucoma surgery. FAZ parameters could be potentially useful modalities to assess vascular reperfusion after glaucoma surgery as, amongst all studied parameters, the area was the most sensitive to surgically induced IOP changes.

XEN Gel Stent in Pseudoexfoliative Glaucoma: 2-Year Results of a Prospective Evaluation.

PRéCIS:: This study confirms the safety and efficacy of XEN gel stents in the management of pseudoexfoliative glaucoma 2 years after implantation, with success rates similar to primary open-angle glaucoma regardless of the definition of success. PURPOSE: To compare the long-term safety and efficacy of XEN gel implant surgery (Allergan Inc., Irvine, CA) in patients with pseudoexfoliative glaucoma (PEXG) and primary open-angle glaucoma (POAG). SETTING: Prospective, interventional study in a tertiary glaucoma center. METHODS: A total of 110 eyes of 85 patients with POAG (57 eyes) or PEXG (53 eyes) and uncontrolled intraocular pressure (IOP) despite medical treatment underwent combined XEN+cataract surgery or standalone XEN surgery. Mean IOP, mean number of medications, needling rates, and incidence of adverse effects were compared between the 2 groups. Complete surgical success was defined as an unmedicated IOP≤12, 15, 16, or 18 mm Hg at 2 years, both with and without a 20% reduction from baseline. RESULTS: Combined XEN+cataract surgery was performed in 72% of POAG and 76% of PEXG eyes (P=0.67), the remainder underwent standalone XEN surgery. Patient characteristics were similar between the 2 groups except for older age for the patients with PEXG (78.5±8.5 vs. 71.3±8.7 y; P<0.005). Mean medicated IOP were 19.8±5.8 mm Hg (POAG) versus 19.8±8.2 mm Hg (PEXG) at baseline (P=0.98), and 14.5±3.6 mm Hg (-26.8%) versus 14.2±3.8 mm Hg (-28.3%), respectively, at 2 years (P=0.75). Mean medications concomitantly dropped from 1.9±1.6 (POAG) versus 2.0±1.3 (PEXG) to 0.6±0.9 versus 0.4±0.7, respectively (P=0.29). Using the 16 mm Hg threshold, 51.4% (POAG) versus 57.1% (PEXG) eyes achieved complete success (P=0.70) at 2 years. The difference in success rates between the 2 groups was not statistically significant under any of the definitions of success. By 24 months, needling was performed in 42.8% (POAG) and 43.2% (PEXG) (P=0.64), with an average time to needling of 162.8 and 134.9 days, respectively (P=0.46). The rates of adverse effects were 30.6% (POAG) and 36.4% (PEXG) (P=0.66), and additional glaucoma surgeries were carried out in 14.3% (POAG) versus 15.9% (PEXG) (P=0.89). CONCLUSIONS: The XEN gel implant as a standalone or combined procedure demonstrated similar efficacy and safety results in PEXG and POAG eyes.

Two-Year Outcomes of XEN Gel Stent Surgery in Patients with Open-Angle Glaucoma.

PURPOSE: To evaluate the 2-year treatment outcomes of the XEN gel stent (Allergan, Inc, Irvine, CA) in glaucoma patients. DESIGN: Prospective, single-center interventional study. PARTICIPANTS: One hundred forty-nine eyes of 113 patients with open-angle glaucoma. METHODS: Consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment were included to undergo either standalone XEN implantation or combined XEN implantation plus phacoemulsification surgery, both with mitomycin C injections. MAIN OUTCOME MEASURES: Primary efficacy outcome was success, defined as complete when the unmedicated IOP was 12 mmHg or less, 15 mmHg or less, or 18 mmHg or less and 20% lower than at baseline over the 2-year period and defined as qualified when the IOP fulfilled the same conditions with fewer medications than at baseline. Secondary measures were mean reduction in IOP and in the number of medications and the rates of reoperations. RESULTS: One hundred nine eyes (84 patients; mean age, 74.3 years) underwent XEN plus phacoemulsification surgery and 40 eyes (29 patients; mean age, 74.7 years) underwent standalone XEN surgery. Overall, 129 eyes (86.6%; 96 eyes of 75 XEN plus phacoemulsification patients and 33 eyes of 24 XEN standalone surgery patients) completed the study. Mean medicated IOP was 20.0±7.5 mmHg at baseline and 14.1±3.7 mmHg at 2 years (P < 0.01), a 29.3% IOP reduction. Mean number of medications dropped from 2.0±1.3 before surgery to 0.6±0.9 at 2 years (P < 0.001). Complete success was achieved in 18.2% of eyes using the 12 mmHg or less and 20% reduction criteria and in 44.4% using the 15 mmHg or less threshold. Needling with mitomycin C was performed in 58 eyes (45%). In all, 11.4% underwent reoperations. CONCLUSIONS: After 2 years, XEN gel stent surgery achieved a clinically and statistically significant reduction both in IOP and the number of antiglaucoma medications, while requiring a high rate of needling interventions.